Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect

NCT06373757 | Completed

• 1 other identifier: RECO6U/5-2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.

Conditions

Chitosan; Nano-hydroxyapatite Hydrogel; Intrabony Defect

Outcome Measures

Primary Outcomes (1)

• Gingival index

  Gingival index (GI) used for the assessment of prevalence and severity of gingivitis. A score from 0 to 3 is given to each area of the tooth.0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. It was evaluated for every patient included in the study, 3 and at 6 months after treatment.

  6 months after treatment

Secondary Outcomes (4)

• Plaque index

  6 months after treatment

• Clinical attachment level

  6 months after treatment

• Periodontal probing depth

  6 months after treatment

• Acrylic stent for pocket assessment

  6 months after treatment

Study Arms (2)

Group I (nano-HAP/Chitosan hydrogel):

EXPERIMENTAL

The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.

Other: Nano-HAP/Chitosan hydrogel

Group II

NO INTERVENTION

Patients were treated with supra and sub-gingival debridement only.

Interventions

Nano-HAP/Chitosan hydrogel OTHER

The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.

Group I (nano-HAP/Chitosan hydrogel):

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 25 to 55 years.
• Both sexes.
• Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.

You may not qualify if:

• Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
• Smokers.
• Pregnant and lactating females.
• Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Giza, 12511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine, Diagnosis and Periodontology Department, Faculty of Dentistry, October 6 University, 6 October city, Egypt

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 18, 2024
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)